| Class 1 Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx o | |
Date Initiated by Firm | January 06, 2014 |
Date Posted | February 21, 2014 |
Recall Status1 |
Terminated 3 on June 17, 2016 |
Recall Number | Z-0958-2014 |
Recall Event ID |
67266 |
510(K)Number | K091761 |
Product Classification |
Tube, tracheal (w/wo connector) - Product Code BTR
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Product | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. |
Code Information |
Product Code: 5-14013, Lot numbers: 01A1200341 and 01B1200423. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr. Research Triangle Park NC 27709
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For Additional Information Contact | Michael T. Taggart 919-572-8014 |
Manufacturer Reason for Recall | The tracheal tube can kink during patient use. |
FDA Determined Cause 2 | Other |
Action | Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881.
Consignees with questions were instructed to call 1-866-246-6990.
For questions regarding this recall call 919-572-8014. |
Quantity in Commerce | 190,871 each (148, 275 US) |
Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BTR
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